Table of contents
- Latest Datascope Intra-Aortic Balloon Pump Lawsuit Updates
- December 11, 2025: FDA Posts Class 2 Cardiosave Hybrid Recall
- May 8, 2024: FDA Urges Providers to Seek Alternatives
- August 31, 2023: FDA Reports Six Class I Recalls
- July 31, 2023: Class I Recall for Over-Temperature Alarms
- June 5, 2023: Class I Recall for Unexpected Shutdowns
- January 9, 2023: Class I Recall for Coiled Cable Failure
- December 19, 2022: Class I Recall for Blood Entering the Pump
- December 2, 2022: FDA Letter on IABP Shortage
- December 22, 2021: FDA Letter on Ongoing Monitoring
- November 19, 2019: FDA Reports More than 60 New Device Reports
- July 23, 2019: FDA Safety Alert on Battery Failure Recall
- November 1, 2018: FDA Letter on Battery-Power Shutdowns
- May 3, 2018: Class 1 Recall for Fluid Ingress
- June 20, 2017: Field Correction for Electrical Test Failure
- What Is an Intra-Aortic Balloon Pump?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- What Does the Research Say About Balloon Pump Failures?
- How Do I Report a Problem with a Cardiosave Balloon Pump?
- Were Datascope Balloon Pumps Sold Outside the United States?
- What Did Datascope Do About the Code #58 Problem?
Datascope Cardiosave and CS-series intra-aortic balloon pumps have been recalled several times because they may shut down or fail to start therapy. The FDA says a failure can lead to unstable blood flow, organ damage or death.
The FDA classified several recalls as Class I, its most serious type. On May 8, 2024, it recommended that health care providers seek alternatives if possible. The newest is a Class 2 Cardiosave Hybrid action posted December 11, 2025.
No lawsuit, class action or MDL has been filed over the pumps. FDA recall notices and complaints reported to the company are the main record of pump failures.
Latest Datascope Intra-Aortic Balloon Pump Lawsuit Updates
December 11, 2025: FDA Posts Class 2 Cardiosave Hybrid Recall
The FDA posted a Class 2 recall of Cardiosave Hybrid pumps in its recall database [1]. Datascope Corp. began the recall, number Z-0916-2026, on November 4, 2025. It covers all serial numbers, 11,470 units in commerce.
An October 2025 urgent correction notice revises preventive maintenance instructions. If an NVRAM battery is older than 8 years, a back-up Cardiosave IABP should be available until it is replaced.
May 8, 2024: FDA Urges Providers to Seek Alternatives
MassDevice reported that the FDA sent a Letter to Health Care Providers about continued safety and quality concerns with Getinge cardiovascular devices, including the Cardiosave IABP [2].
The FDA recommended that providers transition away from these devices and seek alternatives, if possible. It cited continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.
August 31, 2023: FDA Reports Six Class I Recalls
The FDA issued an update letter to health care providers [3]. Since June 2023, Getinge, Maquet and Datascope had started additional voluntary recalls of Cardiosave Hybrid and Rescue pumps.
The FDA identified six of them as Class I. It calls that the most serious type of recall, where use of the devices may cause serious injuries or death. The recalls are voluntary corrections, not product removals.
July 31, 2023: Class I Recall for Over-Temperature Alarms
Datascope, Maquet and Getinge began a Class I correction of Cardiosave Hybrid and Rescue pumps that can overheat [4]. An internal temperature above 176 degrees Fahrenheit can trigger a System Over Temperature alarm that stops therapy.
In the U.S., 4586 devices were distributed. The FDA counts 213 complaints between January 1, 2021 and June 2, 2023, including four injuries and one death.
June 5, 2023: Class I Recall for Unexpected Shutdowns
A Class I recall followed in June 2023 for Cardiosave Hybrid and Rescue pumps that may shut down unexpectedly [5]. The cause is electrical failure of the Power Management Board or Solenoid Board.
Datascope, Maquet and Getinge began the recall. The notice covers 4586 devices in the U.S. and lists 26 complaints. It reports no injuries or death.
January 9, 2023: Class I Recall for Coiled Cable Failure
Datascope and Getinge initiated a Class I recall of Cardiosave Hybrid and Rescue pumps because the coiled cable linking the display and base may fail [6]. A failure can cause an unexpected shutdown without warnings or alarms.
The recall covers an estimated 2,300 devices. The FDA lists 44 complaints from June 2019 to August 2022 and no injuries or deaths. Customers received an Urgent Medical Device Correction letter on February 7, 2023.
December 19, 2022: Class I Recall for Blood Entering the Pump
A burst, leaking or torn balloon can let blood enter a Cardiosave Hybrid or Rescue pump [7]. Datascope and Getinge responded with a Class I recall. Distribution of the pumps ran from March 6, 2012 to the present.
The FDA notice lists 4,454 devices in the U.S. and 134 complaints. They include 12 device shutdowns and 5 adverse events, among them 4 serious injuries and 1 death.
December 2, 2022: FDA Letter on IABP Shortage
The FDA wrote to health care providers about a shortage of Getinge Maquet/Datascope IABP devices [8]. The FDA also added IABP devices, product code DSP, to its medical device shortage list.
According to the letter, supplies of IAB catheters, new Cardiosave IABPs and Cardiosave IABP parts were limited at the time.
December 22, 2021: FDA Letter on Ongoing Monitoring
The FDA sent a letter to providers with updated information about its ongoing evaluation and monitoring of device failures with Getinge Maquet and Datascope Cardiosave Hybrid and Rescue IABP devices.
November 19, 2019: FDA Reports More than 60 New Device Reports
In November 2019 the FDA published an update on Maquet pumps, as reported by DAIC [9]. It counts more than 60 additional medical device reports since the earlier battery recall.
That count includes two patient deaths and one serious patient injury. The FDA said the deaths cannot be definitively attributed to the device shutting down.
July 23, 2019: FDA Safety Alert on Battery Failure Recall
The FDA safety alert classified as Class I a global recall of all Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i pumps for battery failure, according to Medscape [10]. It covers 22,853 devices in the U.S.
Maquet/Datascope was aware of five patient deaths since March 2016. The firm has not concluded they are due solely to the device shutting down on battery power. Customers were notified June 17, 2019.
November 1, 2018: FDA Letter on Battery-Power Shutdowns
In a letter to providers, the FDA described Getinge Maquet and Datascope IABP devices shutting down while running on battery power. The letter followed more than 75 reports since 2017.
May 3, 2018: Class 1 Recall for Fluid Ingress
Maquet Datascope Corp. started a Class 1 recall of CARDIOSAVE Hybrid IABPs, recall number Z-1928-2018 [11]. The recall covers 4300 units.
Ingress of fluids into the device can affect circuit boards and prevent initiation or continuation of therapy. The serial numbers were distributed from March 6, 2012 to April 26, 2018.
June 20, 2017: Field Correction for Electrical Test Failure
The FDA reported a worldwide field correction by Datascope Corp. of CS100i, CS100 and CS300 pumps, according to DAIC [12]. The correction concerns a potential electrical test failure code, #58, linked to one patient death.
About 12,000 units were distributed from March 23, 2003 to December 11, 2013. The company announced the correction on June 15, 2017. The FDA lists the recall as completed and terminated [13].
What Is an Intra-Aortic Balloon Pump?
According to a DAIC report on an FDA letter, the Cardiosave Hybrid and Rescue pump is an electromechanical system that inflates and deflates intra-aortic balloons [14]. It gives temporary support to the heart’s left ventricle through counter pulsation.
The FDA says Cardiosave pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are used in health care facilities.
Who May Be Affected?
People who receive circulatory support from a Cardiosave Hybrid or Rescue pump in a health care facility may be affected. The FDA also lists health care personnel and maintenance or service personnel who work with the pumps.
The over-temperature and shutdown recalls cover pumps distributed from March 6, 2012 to May 19, 2023. The coiled-cable recall covers pumps distributed before July 24, 2017.
The CS300, CS100 and CS100i pumps are no longer made but may still be in use. Related device cases appear on our medical device lawsuits page. Whether a claim exists is a question for an individual legal review.
Reported Injuries or Damages
FDA recall notices describe what a pump failure can cause: “unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death”.
Helium gas bubbles in the blood can damage organs, including the brain. Blood in the pump can expose a later patient to cross-contamination.
The FDA’s May 2024 letter says the extent of the root causes or incidence rate of device failure is not known.
These are agency recall findings and complaints reported to the company. They are not court findings, and they are not proof that a pump caused a specific injury.
Recall and Regulatory Background
Cardiosave Hybrid and Rescue pumps have been the subject of several FDA recalls. A recall does not prove liability. The notices call for customer letters, hardware or software corrections and service visits, and users should have an alternative IABP available.
Health Canada posted a Type II recall, number RA-72511, for the blood-entry issue [15]. It started December 21, 2022 and was posted January 4, 2023.
The Judicial Panel on Multidistrict Litigation has formed no MDL for these pumps [16]. For related heart device cases, see our cardiac catheter lawsuits page.
Evidence to Preserve
Keep records that show which pump was used and what happened:
- Hospital and medical records that show balloon-pump therapy and any interruption in that therapy.
- The pump model and serial number, which the hospital or its biomedical engineering department can give you.
- Any recall or correction letters the hospital received about the pump.
- Copies of any report filed with the FDA about the failure and any reply you received.
- Bills and out-of-pocket costs tied to the treatment and any added care.
- Photographs and a dated account of what happened, written down as soon as you can.
- Messages with the hospital, doctors and the manufacturer about the pump.
Filing Deadlines
Deadlines for injury claims are set by state law. They depend on where you live, when the injury happened and when its cause was discovered.
A lawyer can check which deadline applies to your situation. A missed deadline can end a claim even when the facts are strong, so ask promptly.
Frequently Asked Questions
What Does the Research Say About Balloon Pump Failures?
The research on balloon pump failures comes from FDA letters. In August 2023 the FDA said these pumps may continue to be used to provide circulatory support when necessary, while it remained concerned about device shutdown and pump stop events.
How Do I Report a Problem with a Cardiosave Balloon Pump?
You can report a problem with a Cardiosave balloon pump to the FDA. Datascope/Getinge Technical Support also takes calls at 1-888-943-8872, options 4, 2, 1, Monday through Friday, 8:00 a.m. to 6:00 p.m. Eastern.
Were Datascope Balloon Pumps Sold Outside the United States?
Datascope balloon pumps were sold outside the United States. Datascope said the pumps in its June 2017 correction were sold globally in over 100 countries. The 2019 battery recall was also global.
What Did Datascope Do About the Code #58 Problem?
Datascope said it would replace the defective solenoid driver boards for the code #58 problem. In the complaint linked to the patient death, a CS300 IABP did not pump. Code #58 occurs when a solenoid valve needs more power than the board can deliver.